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IND Filing

ST&T's ability to develop successful drug approval strategy is well known among our clients. Ronald J. Amen, Ph.D., who leads our staff in these activities, has over 30 years of experience in corporate and consulting drug development. Dr. Amen was Director of Product Development and Clinical Research at McGaw Laboratories (now part of Baxter). In this capacity his departments were responsible for the preparation of drug-application and development documents; all of which were accepted by the FDA. After leaving industry, Dr. Amen began consulting in the drug development strategy and regulatory affairs arenas with start-up pharmaceutical companies. Since drug approval is initially driven by the correct IND filing strategy, Dr. Amen personally directs this function. His strategies led to acceptance of every IND that our clients filed under his tutelage. Dr. Amen presently sits on the Board of Directors of a number of our clients’ companies where he continues to manage the various drug approval strategies by directing the preparation of Annual Reports, Orphan Drug Submissions, and Phase 1 and Phase 2 protocols. An additional key member of the ST&T Regulatory Team is Dr. Wally Winters, a long-time FDA drug official who provides invaluable insight and direction to the company's drug strategies. .

 




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